Comparison of the Multi-Test II and Skintestor Omni allergy skin test devices.
ABSTRACT Different devices for percutaneous allergy skin testing have demonstrated statistically and clinically significant differences in performance characteristics.
To compare 2 Food and Drug Administration-approved multihead allergy skin testing devices: Multi-Test II (Lincoln Diagnostics) and Skintestor Omni (Greer Laboratories).
Skin tests with glycerinated histamine (6-mg/mL base) and glycerinated saline were applied to 31 adults using Multi-Test II on the volar surface of one forearm and Skintestor Omni on the opposite forearm.
Data were accumulated from 155 histamine sites and 93 negative control sites for each device. Using cutoff wheal sizes of 5 vs 3 mm inclusive to define a positive result, Multi-Test II sensitivity remained at 100%, but specificity increased from 74% to 97%, whereas Skintestor Omni sensitivity decreased from 94% to 87%, and specificity increased from 58% to 88%. For Multi-Test II vs Skintestor Omni, histamine mean (SD) wheal sizes were 9.23 (1.37) vs 7.74 (2.83) mm (P < .001), mean coefficients of variance were 14.8% vs 36.6%, and pooled estimates of variance were 0.642 vs 6.974. Multi-Test II produced similar histamine wheal sizes regardless of test head position used, whereas Skintestor Omni produced statistically significantly smaller wheals at certain test head positions.
Multi-Test II had higher sensitivity and specificity than Skintestor Omni and produced reproducible wheal sizes from all test head positions. Because some Skintestor Omni test head positions produced significantly smaller histamine wheal sizes, skin testing using this device might result in underdiagnosis of allergy.
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ABSTRACT: Five commercially available devices for performing prick skin testing were compared for reproducibility, patient acceptance, occurrence of false-negative skin test results, and size distribution of reactions at the negative control sites. Reproducibility of skin testing with 10 mg/ml histamine base, as expressed by coefficient of variation, was similar. However, a clear range of trauma to the skin was produced by the devices. This trauma was least with the Hollister-Stier and ALK Laboratories lancets, intermediate for the bifurcated needle by either prick or puncture, and greatest for the Multi-Test and DermaPIK devices. The more traumatic devices produced larger mean wheals and more frequent and large reactions at saline control sites, and were less acceptable to subjects. However, except for the Multi-Test device, they less often yielded false-negative responses. It is proposed that for each device a different size of wheal must be produced at the allergen site to have confidence that it exceeds the control site. The wheal size necessary for 99% specificity were as follows: Hollister-Stier lancet, 2 mm; ALK lancet, 3.0 mm; bifurcated needle prick, 4.0 mm; bifurcated needle puncture, 4.5 mm; Multi-Test device, 5.0 mm; and DermaPIK device, 5.5 mm. An additional observation was the presence of a significant gradient of reaction size on the back to both histamine and allergen (p < 0.0001), with the smallest reactions in the upper third and the largest in the lower third of the back.Journal of Allergy and Clinical Immunology 11/1993; 92(5):750-6. · 12.05 Impact Factor
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ABSTRACT: Allergy skin testing guides developing avoidance plans and writing an immunotherapy prescription. The goal for the allergist is to apply allergen skin testing to the appropriate patient population by using a device that minimizes both false-negative and false-positive findings while minimizing patient discomfort. New skin testing devices continue to be developed with a trend toward production of multiheaded devices. Data on the performance of these devices in a head-to-head prospective fashion are limited. Our goal was to study 8 commonly used devices to compare their performance in a head-to-head fashion. In a prospective, double-blind fashion, the performance of 8 skin test devices was evaluated. Devices were tested with histamine and saline on both the arms and back of each subject. Devices were rotated over 4 testing sessions, at least a week apart, so each device was tested in each anatomic testing location. Performance elements examined included wheal, flare, pain, sensitivity, specificity, and intradevice variability. We found significant differences in all areas of device performance among all devices examined. Multiheaded devices also demonstrated significant intradevice variability and were more painful than single devices. Furthermore, multiheaded devices had larger reactions on the back, whereas single devices had larger reactions on the arms. Statistically significant differences exist among all devices tested. Providers should consider this data when choosing a device that suits their practice setting and ensure that technicians are sufficiently trained on the correct use of that device.Journal of Allergy and Clinical Immunology 09/2005; 116(2):341-6. · 12.05 Impact Factor
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ABSTRACT: Background: Previous comparisons of devices for percutaneous skin testing have revealed statistically and clinically significant differences, from one device to another, in the size of reactions to histamine and allergen extracts and at negative control sites.Objective: The objective of this study was to compare the performance of several skin test devices which are either new, modified, or used with a modified technique.Methods: Twenty subjects were tested five to eight times with each of the devices both to glycerol-saline and to 10 mg/ml histamine base. The devices tested were the MultiTest II, Duo Tip-Test (prick and scarification), Quintest, DermaPik (prick and scarification), and small pox needle.Results: There were highly significant differences among the devices for the size of the reaction to histamine (mean wheal diameter 4.28 to 8.59 mm, p < 0.0001), the standard errors of the wheals to histamine (0.82 to 1.45 mm, p < 0.05) and in the mean wheal size with glycerol-saline (0.00 to 2.48 mm, p < 0.0001).Conclusions: Devices for performing skin prick testing vary greatly in several characteristics, including the size of reactions at both positive and negative test sites. Each skin test technician should be tested with the device used in that skin testing laboratory to establish criteria for positive and negative tests. (J Allergy Clin Immunol 1998;101:153-6.)Journal of Allergy and Clinical Immunology 02/1998; · 12.05 Impact Factor